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GeneProof Mycoplasma pneumoniae PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

HIGH SENSITIVITY AND SPECIFICITY

  • Secured by targeting the multicopy sequence of the M181 gene

CONTAMINATION ELIMINATION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products

UNIVERSAL PCR PROFILE

  • Enables rapid and sensitive detection of disease-causing agents of atypical pneumoniae

  • Beneficial in combination with GeneProof Chlamydia pneumoniae PCR Kit and GeneProof Bordetella pertussis/parapertussis PCR Kit
  • Simplifies laboratory workflow

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof Mycoplasma pneumoniae PCR Kit MP/ISEX/025 real-time PCR 25 reactions
GeneProof Mycoplasma pneumoniae PCR Kit MP/ISEX/050 real-time PCR 50 reactions
GeneProof Mycoplasma pneumoniae PCR Kit MP/ISEX/050 real-time PCR 100 reactions

EQA Panels

EQA results

GP_Instand_06.2019_EN
pdf, [416.54 kB]
GP_Instand_06.2020_EN
pdf, [316.96 kB]
Choose all

Technical specification

Technology real-time PCR
Type of Analysis qualitative
Target Sequence the M181 gene encoding the CARDS toxin
Analytical Specificity

M. pneumoniae, 100 % 

Analytical Sensitivity (LoD)

reaches up to 0.46 cp/μl with the probability of 95 %

Extraction/Inhibition Controls

PCR inhibition and DNA extraction efficiency control 

Validated Specimen BAL, sputum, swab
Storage -20 ± 5 °C
Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
Instruments

croBEE Real-Time PCR System*
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
LightCycler® 2.0 / 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR System

Required Detection Channels FAM, HEX
External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment panels - results at www.geneproof.com
Certification CE IVD

* Validated instruments

 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.45 MB]
GP_Declaration of Change_EN_CZ
pdf, [201.13 kB]
GP_MP_Instruction for Use_EN
pdf, [542.96 kB]
GP_MP_Instruction for Use_ES
pdf, [193.6 kB]
GP_MP_Leaflet_EN
pdf, [142.93 kB]

Declaration of Conformity

GP_MP_Declaration of Conformity_EN
pdf, [310.52 kB]

MSDS

GP_Safety Data Sheet_EN
pdf, [148.84 kB]

Manual

AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 2.0_EN
pdf, [1.94 MB]
LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
Mic qPCR Cycler_EN
pdf, [2.33 MB]
QuantStudio 3/5 Real-Time PCR System_EN
pdf, [2.29 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]

PCR Template

GP_Mycoplasma pneumoniae_Mic_1
micassay, [21.95 kB]
Files are available only for registered users.